Quality Engineering & Validation Leader

Baxter

Round Lake Beach (IL)

On-site

USD 112,000 - 154,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

401(k) Retirement Savings Plan

Paid time off 20-35 days

Job summary

Baxter is seeking a Quality Validation leader in the United States (Illinois) to shape the site validation program and data integrity governance. You will partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive compliant, efficient oversight while maintaining QA independence.

Ideal candidates bring expert cGMP validation knowledge, data integrity governance, and leadership experience in complex remediation programs, with strong regulatory acumen and

Qualifications

Expert knowledge of cGMP validation, GAMP 5, and 21 CFR Part 11.
Proven governance of data integrity and ALCOA+ principles.

Responsibilities

Establish QA governance for validation and data integrity at the site.
Lead and manage the Quality Engineering team.
Ensure accountability across owners for validation activities.
Approve validation master plans and deviation handling.
Lead governance forums and align with regulatory expectations.
Represent programs during FDA inspections and audits.
Develop training and tools for QA and partners.
Drive continuous improvement while preserving QA independence.

Skills

Leadership

Regulatory knowledge

Communication

Decision making

Risk management

Education

Bachelor's degree in Engineering/Science/CS

Tools

GAMP 5

Job description

Ideal candidates bring expert cGMP validation knowledge, data integrity governance, and leadership experience in complex remediation programs, with strong regulatory acumen and

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